Phase I/II Study of Total Body Irradiation, Cyclophosphamide, and Fludarabine Followed by Alternate Donor Hematopoietic Cell Transplantation in Patients With Fanconi's Anemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005898|
Recruitment Status : Completed
First Posted : June 5, 2000
Last Update Posted : June 24, 2005
OBJECTIVES: I. Determine the probability of engraftment with total body irradiation, cyclophosphamide, fludarabine, and anti-thymocyte globulin followed by HLA nongenotypically identical donor, T-cell depleted hematopoietic cell transplantation in patients with Fanconi's anemia.
II. Determine the incidence of acute and chronic graft-versus-host disease in these patients after undergoing this treatment regimen.
III. Determine the one-year survival rate in these patients after undergoing this treatment regimen.
IV. Determine the toxicity of this treatment regimen in these patients. V. Determine the incidence of relapse in patients with myelodysplastic syndrome or acute myeloid leukemia after undergoing this treatment regimen.
|Condition or disease||Intervention/treatment||Phase|
|Fanconi's Anemia||Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: fludarabine Drug: methylprednisolone||Phase 1 Phase 2|
PROTOCOL OUTLINE: Donor bone marrow, peripheral blood, or umbilical cord blood is processed to harvest CD34+ cells.
Patients receive preparative cytoreductive therapy comprising total body irradiation on day -6; cyclophosphamide IV over 2 hours on days -5 to -2; fludarabine IV over 30 minutes on days -5 to -2; methylprednisone IV on days -5 to 24; anti-thymocyte globulin IV over 4-6 hours on days -5 to -1; cyclosporine IV over 2 hours every 12 hours (every 8 hours for patients less than 40 kg in weight) on days -3 to 180, and then tapering in the absence of graft-versus-host disease; hematopoietic cell transplantation on day 0; and filgrastim (G-CSF) IV starting on day 1 and continuing until blood counts recover.
Patients are followed at days 60, 90, and 180, and then annually for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Study Start Date :||February 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005898
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||John E. Wagner, Jr.||Masonic Cancer Center, University of Minnesota|